An example of how to handle amorphous fractions in API during early pharmaceutical development: SAR114137--a successful approach.

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第一作者： Christine,Petzoldt

第一单位： Sanofi-Aventis Deutschland GmbH, Chemical and Biotechnological Development (C&BD) Frankfurt Chemistry, Frankfurt, Germany. Electronic address: Christine.petzoldt@sanofi.com.

作者： Christine,Petzoldt ^[1] ; Oliver,Bley ^[2] ; Stephen J,Byard ^[3] ; Doris,Andert ^[4] ; Bruno,Baumgartner ^[4] ; Norbert,Nagel ^[4] ; Christoph,Tappertzhofen ^[5] ; Martin Philipp,Feth ^[6]

作者单位： Sanofi-Aventis Deutschland GmbH, Chemical and Biotechnological Development (C&BD) Frankfurt Chemistry, Frankfurt, Germany. Electronic address: Christine.petzoldt@sanofi.com. ^[1] Sanofi-Aventis Deutschland GmbH, R&D, LGCR, Pharmaceutical Operations, Frankfurt, Germany. ^[2] Covance Laboratories, Alnwick, Northumberland, United Kingdom. Electronic address: Stephen.Byard@covance.com. ^[3] Sanofi-Aventis Deutschland GmbH, R&D, LGCR, Analytical Development, Frankfurt, Germany. ^[4] Sanofi-Aventis Deutschland GmbH, Chemical and Biotechnological Development (C&BD) Frankfurt Chemistry, Frankfurt, Germany. ^[5] Sanofi-Aventis Deutschland GmbH, Chemical and Biotechnological Development (C&BD) Frankfurt Chemistry, Frankfurt, Germany. Electronic address: Martinphilipp.feth@sanofi.com. ^[6]

关键词 Amorphous content Differential Scanning Calorimetry (DSC)Jet milling Micronisation Pharmaceutical solid chain Solid-state Nuclear Magnetic Resonance (ssNMR)

主题词镇痛药(Analgesics);化学, 药物(Chemistry, Pharmaceutical);药物发现(Drug Discovery);光谱分析, 拉曼(Spectrum Analysis, Raman);X线衍射(X-Ray Diffraction)

DOI 10.1016/j.ejpb.2013.09.015

PMID 24075979

发布时间 2014-04-11

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准确一般字义偏差语意偏离译文作用小提交